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GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05430373
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Grit Biotechnology

Study Description
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Brief Summary:

This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, clear lung pretreatment period, treatment and observation period, and follow-up period.

The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：

  1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
  2. GT101 infusion.
  3. post-infusion treatment (interleukin-2 intravenous push).

Condition or disease Intervention/treatment Phase
Solid Tumors, Adult Biological: GT101 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
GT101 treatment group
Autologous tumor infiltrating lymphocyte injection
 Biological: GT101
Autologous tumor infiltrating lymphocyte injection


Outcome Measures
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Primary Outcome Measures :
  1. Safety Profile Measured by Grade ≥3 TEAEs [ Time Frame: 3 years ]
    To characterize the safety profile of autologous TIL injection（GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)

  2. Objective response rate [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3. Progression-free survival [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

  4. Overall survival [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Overall Survival (OS)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
  • 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
  • 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
  • 4.Any anti-tumor therapy should be stopped at least 28 days before NMA lymphodepletion pretreatment;

Exclusion Criteria:

  • 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
  • 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
  • 3. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
  • 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
  • 5. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
  • 6. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same
  • 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
  • 8.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430373


Contacts
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Contact: Haifeng Qin, PhD +86 13601365243 hifo@263.net
Contact: Yongsheng Wang, PhD wangy756@163.com

Locations
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China, Beijing
The fifth medical center of the General Hospital of the Chinese people's Liberation Army Recruiting
Beijing, Beijing, China, 100039
Contact: Haifeng Qin, PhD    +86 13601365243    hifo@263.net   
China, Chongqing
Chongqing University Cancer Center Recruiting
Chongqing, Chongqing, China, 400030
Contact: Donglin Zou, PhD       13570049@qq.com   
Contact: Yongsheng Li, PhD       yongshengli2005@163.com   
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 201321
Contact: Jian Zhang, PhD       syner2000@163.com   
Contact: Dongmei Ji, PhD         
China, Sichuan
West China School of Medicine/West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610064
Contact: Yongsheng Wang, PhD       wangy756@163.com   
China, Tianjin
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Xiubao Ren, PhD       xiubao_ren@126.com   
Sponsors and Collaborators
Grit Biotechnology
More Information
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Responsible Party: Grit Biotechnology
ClinicalTrials.gov Identifier: NCT05430373    
Other Study ID Numbers: GT101-101
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms